Process Validation (Track 2)

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The workshop will include leveraging Process Validation Stage 1 (development) information, determining process validation acceptance criteria, sampling plans, determining the number of batches for Process Validation Stage 2, determining an appropriate level of heightened sampling, and testing post Process Validation (Lifecycle Stage 3).

Attendees will have the chance to discuss, benchmark, and practice application (through use of interactive exercises) of practical approaches for satisfying lifecycle process validation expectations. You will also be able to hear regulator reactions to approaches, as regulators participate throughout this session, including strengths and opportunities for improvement. Participants will have the opportunity to voice concerns, ask for clarification and provide recommendation to the recent EMA PV Draft Guidance directly to regulators. Electronic polling will be utilised to capture implementation status and approaches of various other companies participating in the session. (Download the agenda ( 19 KB))

At the conclusion of this session, participants will be able to:

  • Gain insight into the practical impacts of the lifecycle approach to PV
  • Gain clarity around the content of the FDA PV Guidance and EMA PV Draft Guidance concepts
  • Understand approaches and thinking from industry and regulatory leaders
  • Explain implementation options and status


  • Joanne Barrick, Advisor, Global Validation Support, Eli Lilly & Co., USA
  • Penny Butterell, Senior Validation Manager, Pfizer, Belgium

Some of the sessions will cover: 

IMB/EMA View of PV Lifecycle Approach and Objectives and Impact of EMA PV Draft Guidance
Catherine  McHugh, Irish Medicines Board, Ireland

Implementation and Validation of PAT in Pharma Industry - A Regulator's Perspective
Keith Pugh, Licensing Division Expert Assessor, MHRA, United Kingdom

Case Study: Number of Batches
Richard Kettlewell, Head, Product Quality Lifecycle Management, GlaxoSmithKline, United Kingdom

Sampling within and across batches to take decisions with confidence
Per Vase, Statistics Senior Specialist, NNE Pharmaplan, Denmark

The presentation will focus on how to use capability indices to describe quality and how many samples is needed to release a batch and how many batches is needed in a validation to take decision with confidence. When samples shall be taken by time or event will be discussed. Examples from pharmaceutical production will be shown.